FDA 510(k) Application Details - K222199

Device Classification Name

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510(K) Number K222199
Device Name Collagen P.I.N. (Percutaneous Induction Needling)
Applicant Induction Therapies LLC
1920 Stanley Gault Parkway, Suite 100
Louisville, KY 40223 US
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Contact Amelia Aslam
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Regulation Number

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Classification Product Code QAI
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Date Received 07/22/2022
Decision Date 10/21/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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